At Getinge we have the passion to perform
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge, our passion is to secure that every person and community have access to the best possible care, offering hospitals and life science institutions products and solutions that aim to improve clinical results and optimize workflows. Every day we collaborate to make a true difference for our customers – and to save more lives.
Are you looking for an inspiring career? You just found it.
Do you want to take your next career step into a global medtech company? At Getinge Disinfection in Växjö we are developing and manufacturing disinfector solutions for hospitals worldwide. Now, Getinge Disinfection is looking for a Quality Engineer with the role as a coordinator for corrective and preventive actions (CAPA). You will be a member of the Quality team and this position offers you an opportunity to work cross-functional locally and globally with a wide variety of stakeholders inside and outside the organization.
The Position
Medical Device safety and Quality Compliance is a top priority commitment at Getinge to save lives and maintain customer trust. As a Quality engineer and CAPA coordinator, we trust you to bring in your experience and knowledge from quality and compliance to help us improve our ways of working, leading us to better product quality and higher customer satisfaction.
You will be a part of the Quality- and Regulatory affairs team in the Växjö site consisting of nine people being ambassadors for the compliance to medical device regulations, as well as other applicable standards and regulations. In this team, we are responsible for regulatory activities in project development projects, the quality management system as well as performing supplier and internal audits. We also lead the activities related to product registrations, customer complaints, Corrective and Preventive Actions (CAPA) and Management Review, among other things.
We are passionate about improvements and love to find new efficient ways of working while keeping the compliance. In this position, you will report to the Quality Manager in Växjö.
Your main responsibilities and tasks will be:
- Supporting the organization in successful compliance to the CAPA process for the whole site.
- Responsible for local CAPA Review Board (CRB)
- Support CAPA owners and CAPA team during the CAPA process and make sure relevant documentation are managed
- Participate in preparation of external audits, management reviews and post market surveillance reports
- Within your area of expertise, support the organization e.g. participate in standardization, and continuously improve our processes.
Who are you
To be successful in this role we think you have the following background:
Bachelor or Master Degree in the field of medical device, electronics, mechanical engineering or similar- 3-5 years of experience in Quality Management / Reg. Affairs or related functions within a medical device or other regulated environment
- Previous background and experience within other related functions, including product development, manufacturing, and operations
- Experience and good knowledge in applicable regulations and standards, e.g. ISO 13485:2016, MDSAP, MDD, MDR and ISO 14971.
- Very good Swedish and English skills, oral and written
Personal skills
As a person you are action-oriented, driven and independent with a great amount of integrity. To succeed in the position you must have excellent documentation and communication skills.
You are strategic thinking but pragmatic with a strong ability to make decisions. You also have a coherent, challenging and process-oriented attitude and an excellent ability to communicate and collaborate with both internal and external stakeholders.
Application
If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application and resume. We hope you will join us on our journey to become the world’s most respected and trusted medtech company. Please send your application no later than May 5th. If you have any questions regarding this position, please contact Maria Elovsson on email: maria.elovsson@getinge.com
About us
Getinge is on an exciting transformation journey constantly looking for new ways to innovate together with our customers to meet the healthcare challenges of the future. We are committed to diversity, equity and inclusion and to sustainability with a goal to be CO2 neutral by 2025. We believe in giving our employees the flexibility they need and make every effort to foster a learning culture that supports their personal development and creativity. Our passionate people hold our brand promise ‘Passion for Life’ close to heart.
If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application and resume. We hope you will join us on our journey to become the world’s most respected and trusted medtech company.
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